Surgical Wound InfectionPhase 3NCT07142408
The Effect of Bacterial Decolonization Before Skin Cancer Surgery on Infection Rate of Lower Extremity Wounds Left Open to Heal
A Phase 3 study testing Chlorhexidine gluconate (4%) and Mupirocin 2% Ointment in people with Surgical Wound Infection, run by Cooper Norcross Health at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if reducing bacterial load on the skin and nostrils with topical antibacterial soap and ointment, respectively, reduces rate of infection in surgical sites on lower leg wounds left open to heal in adults undergoing skin cancer surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Wound Infection
- What is being tested?
- Chlorhexidine gluconate (4%) and Mupirocin 2% Ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 848 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2023to Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age at least 18 years old
- Scheduled to undergo surgical treatment for skin cancer on the lower extremities and have no other surgeries scheduled in the coming weeks after the procedure
- Will have a surgical wound that will be left open to heal by secondary intention
Who cannot join
- Age under 18 years old
- Have a known allergy to chlorhexidine or mupirocin
- Have a history of Staphylococcus aureus infection
- Have a history of heart valve or joint replacement surgery requiring pre-operative antibiotics
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Center for Dermatologic Surgery at Cooper University Health Care
Marlton, New Jersey, 08053
Naomi Lawrence, MD, 856-596-3040, lawrence-naomi@cooperhealth.edu
Faria Nusrat, BS, (856) 596-3040, nusrat-faria@cooperhealth.edu
About this study
Official title: The Effect of Pre-Operative Bacterial Decolonization on Post-Operative Infection Rate for Lower Extremity Wounds Healing by Second Intention
The goal of this clinical trial is to learn if reducing bacterial load on the skin and nostrils with topical antibacterial soap and ointment, respectively, reduces rate of infection in surgical sites on lower leg wounds left open to heal in adults undergoing skin cancer surgery.
The main question it aims to answer is:
Read more
Does Hibiclens antibacterial skin cleanser and mupirocin antibacterial ointment applied to nostrils prior to surgery lower the number of times participants develop an infection in their open wound on the lower leg?
Researchers will compare the treatment group to the standard of care, which involves no treatment prior to surgery, to see if topical antibiotics applied prior to surgery affect infection rates between the two groups.
Participants randomized to the treatment group will:
Shower with Hibiclens once daily for 5 days prior to the day of surgery and apply mupirocin to the nostrils twice daily for 5 days prior to the day of surgery. They will then send pictures of their surgical site to monitor for signs of infection at 2-week and 4-week post-operation.
Participants randomized to the control group (standard of care) will:
NOT apply the topical antibacterials prior to the day of surgery. They will then send pictures of their surgical site to monitor for signs of infection at 2-week intervals for 1 month after surgery.
Read the detailed description
The goal of this clinical trial is to learn if reducing bacterial load on the skin and nostrils with topical antibacterial soap and ointment, respectively, reduces rate of infection in surgical sites on lower leg wounds left open to heal in adults undergoing skin cancer surgery.
The main question it aims to answer is:
Does Hibiclens antibacterial skin cleanser and mupirocin ointment applied to nostrils prior to surgery lower the number of times participants develop an infection in their open wound on the lower leg?
Researchers will compare the treatment group to the standard of care, which involves no treatment prior to surgery, to see if topical antibiotics applied prior to surgery affect infection rates between the two groups.
Participants randomized to the treatment group will:
- Shower with Hibiclens (Chlorhexidine Gluconate Solution 4% w/v) once daily for 5 days prior to the day of surgery
- Apply 2% mupirocin ointment to the nostrils twice daily for 5 days prior to the day of surgery
- Come into the office for their skin cancer surgery. They will be provided with standard wound care instructions, which entails daily gentle cleansing with soap/water, pat dry, then apply Vaseline, nonadherent gauze, and paper tape.
- Send pictures of their surgical site at 2-week and 4-week post-operation, which will be monitored for signs of infection by the study physicians.
- If there's a concern for infection, they will come into the office to swab the wound site to determine the cause of infection. If there's no concern for infection, they will not need to return to the office.
Participants randomized to the control group (standard of care) will:
- NOT apply the topical antibacterials prior to the day of surgery
- Come into the office for their skin cancer surgery. They will be provided with standard wound care instructions, which entails daily gentle cleansing with soap/water, pat dry, then apply Vaseline, nonadherent gauze, and paper tape.
- Send pictures of their surgical site at 2-week and 4-week post-operation, which will be monitored for signs of infection by the study physicians.
- If there's a concern for infection, they will come into the office to swab the wound site to determine the cause of infection. If there's no concern for infection, they will not need to return to the office.
- Conditions
- Surgical Wound Infection
- Being tested
- Chlorhexidine gluconate (4%), Mupirocin 2% Ointment
- Keywords
- Lower Extremity Wound, Skin Cancer Surgery, Infection Rate, Prophylactic Topical Antibiotics, Chlorhexidine, Mupirocin, Wound Healing, Secondary Intention, Infection Prevention
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine gluconate (4%)Drug
Also called Hibiclens
Chlorhexidine 4% solution will be applied from the neck down (avoiding the face, penis, and vagina), allowed to sit on the skin for one minute, then rinsed off in the shower every day for 5 days prior to surgery.
Mupirocin 2% OintmentDrug
Mupirocin 2% ointment will be applied to the inside of the nostrils twice daily, in the morning and evening, for 5 days prior to surgery. A small amount of the ointment will be placed on the tip of a cotton swab to facilitate application to each nostril.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | This group will be prophylactically treated with topical antibiotics every day for 5 days prior to surgery. Participants will shower with Hibiclens antiseptic skin cleanser once daily and apply mupirocin ointment to the nares twice daily, in the morning and evening. Receives: Drug: Chlorhexidine gluconate (4%); Drug: Mupirocin 2% Ointment |
| Control Group | No intervention | This group will NOT be prophylactically treated with Hibiclens antiseptic skin cleanser and mupirocin ointment prior to surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Surgical Site Wound Infection
Signs of infection, including erythema, edema, drainage, and delayed healing, will be visually determined by study physicians with photographs of the surgical site collected from study participants. All patients will be followed up with a phone call at 1 month to monitor for any adverse events and additional signs of infection including pain, tenderness, warmth, and foul odor at the surgical site.
Measured: From date of surgery to 1-month post-operation
Secondary outcomes (1)
Type of Pathogens Present in Surgical Site
Study participants with signs of infection, as determined by the study physicians from photos of the wound, will return to the office for a wound culture to determine the type of pathogen causing the infection.
Measured: From date of surgery to 1-month post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start13 Mar 2023
- Primary completionOct 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Surgical Wound InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 848 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cooper Norcross Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis, Washington University School of Medicine, Baylor College of Medicine, Princeton Healthcare System, The Cleveland Clinic, University of Georgia, St. Luke's Hospital and Health Network, Pennsylvania
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142408
- Sponsor's protocol ID
- Cooper IRB Number 21-119
- Status last verified
- Aug 2025
- First submitted
- 29 Jul 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We have not decided whether or not individual participant data (IPD) will be shared, however, if we do, only IPD used in the results publication will be included.
Publications
Smith H, Borchard K, Cherian P, Tai Y, Vinciullo C. Randomized Controlled Trial of Preoperative Topical Decolonization to Reduce Surgical Site Infection for Staphylococcus aureus Nasal Swab-Negative Mohs Micrographic Surgery Patients. Dermatol Surg. 2019 Feb;45(2):229-233. doi: 10.1097/DSS.0000000000001662.
PubMed 30204741Cherian P, Gunson T, Borchard K, Tai Y, Smith H, Vinciullo C. Oral antibiotics versus topical decolonization to prevent surgical site infection after Mohs micrographic surgery--a randomized, controlled trial. Dermatol Surg. 2013 Oct;39(10):1486-93. doi: 10.1111/dsu.12318.
PubMed 24090258Molina GE, Yu SH, Neel VA. Observations Regarding Infection Risk in Lower-Extremity Wound Healing by Second Intention. Dermatol Surg. 2020 Oct;46(10):1342-1344. doi: 10.1097/DSS.0000000000002094. No abstract available.
PubMed 31415257Dixon AJ, Dixon MP, Askew DA, Wilkinson D. Prospective study of wound infections in dermatologic surgery in the absence of prophylactic antibiotics. Dermatol Surg. 2006 Jun;32(6):819-26; discussion 826-7. doi: 10.1111/j.1524-4725.2006.32167.x.
PubMed 16792648Liu X, Sprengers M, Nelemans PJ, Mosterd K, Kelleners-Smeets NWJ. Risk Factors for Surgical Site Infections in Dermatological Surgery. Acta Derm Venereol. 2018 Feb 7;98(2):246-250. doi: 10.2340/00015555-2844.
PubMed 29136259Schimmel J, Belcher M, Vieira C, Lawrence N, Decker A. Incidence of Surgical Site Infections in Second Intention Healing After Dermatologic Surgery. Dermatol Surg. 2020 Dec;46(12):1492-1497. doi: 10.1097/DSS.0000000000002409.
PubMed 32483093
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pre-Operative Bacterial Decolonization on Post-Operative Infection Rate for Lower Extremity Wounds Healing by Second Intention
- ClinicalTrials.gov ID
- NCT07142408
- Acronym / sponsor ID
- Cooper IRB Number 21-119
- Conditions
- Surgical Wound Infection
- Keywords
- Lower Extremity Wound, Skin Cancer Surgery, Infection Rate, Prophylactic Topical Antibiotics, Chlorhexidine, Mupirocin, Wound Healing, Secondary Intention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 848 participants (estimated)
- Lead sponsor
- Cooper Norcross HealthUniversity, hospital or other
- Collaborators
- University of California, Davis, Washington University School of Medicine, Baylor College of Medicine, Princeton Healthcare System, The Cleveland Clinic, University of Georgia, St. Luke's Hospital and Health Network, Pennsylvania
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- Oct 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if reducing bacterial load on the skin and nostrils with topical antibacterial soap and ointment, respectively, reduces rate of infection in surgical sites on lower leg wounds left open to heal in adults undergoing skin cancer surgery.
The main question it aims to answer is:
Does Hibiclens antibacterial skin cleanser and mupirocin antibacterial ointment applied to nostrils prior to surgery lower the number of times participants develop an infection in their open wound on the lower leg?
Researchers will compare the treatment group to the standard of care, which involves no treatment prior to surgery, to see if topical antibiotics applied prior to surgery affect infection rates between the two groups.
Participants randomized to the treatment group will:
Shower with Hibiclens once daily for 5 days prior to the day of surgery and apply mupirocin to the nostrils twice daily for 5 days prior to the day of surgery. They will then send pictures of their surgical site to monitor for signs of infection at 2-week and 4-week post-operation.
Participants randomized to the control group (standard of care) will:
NOT apply the topical antibacterials prior to the day of surgery. They will then send pictures of their surgical site to monitor for signs of infection at 2-week intervals for 1 month after surgery.
Detailed description
The goal of this clinical trial is to learn if reducing bacterial load on the skin and nostrils with topical antibacterial soap and ointment, respectively, reduces rate of infection in surgical sites on lower leg wounds left open to heal in adults undergoing skin cancer surgery.
The main question it aims to answer is:
Does Hibiclens antibacterial skin cleanser and mupirocin ointment applied to nostrils prior to surgery lower the number of times participants develop an infection in their open wound on the lower leg?
Researchers will compare the treatment group to the standard of care, which involves no treatment prior to surgery, to see if topical antibiotics applied prior to surgery affect infection rates between the two groups.
Participants randomized to the treatment group will:
- Shower with Hibiclens (Chlorhexidine Gluconate Solution 4% w/v) once daily for 5 days prior to the day of surgery
- Apply 2% mupirocin ointment to the nostrils twice daily for 5 days prior to the day of surgery
- Come into the office for their skin cancer surgery. They will be provided with standard wound care instructions, which entails daily gentle cleansing with soap/water, pat dry, then apply Vaseline, nonadherent gauze, and paper tape.
- Send pictures of their surgical site at 2-week and 4-week post-operation, which will be monitored for signs of infection by the study physicians.
- If there's a concern for infection, they will come into the office to swab the wound site to determine the cause of infection. If there's no concern for infection, they will not need to return to the office.
Participants randomized to the control group (standard of care) will:
- NOT apply the topical antibacterials prior to the day of surgery
- Come into the office for their skin cancer surgery. They will be provided with standard wound care instructions, which entails daily gentle cleansing with soap/water, pat dry, then apply Vaseline, nonadherent gauze, and paper tape.
- Send pictures of their surgical site at 2-week and 4-week post-operation, which will be monitored for signs of infection by the study physicians.
- If there's a concern for infection, they will come into the office to swab the wound site to determine the cause of infection. If there's no concern for infection, they will not need to return to the office.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: Chlorhexidine gluconate (4%), Drug: Mupirocin 2% OintmentThis group will be prophylactically treated with topical antibiotics every day for 5 days prior to surgery. Participants will shower with Hibiclens antiseptic skin cleanser once daily and apply mupirocin ointment to the nares twice daily, in the morning and evening. |
| Control Group | No intervention | –This group will NOT be prophylactically treated with Hibiclens antiseptic skin cleanser and mupirocin ointment prior to surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age at least 18 years old
- Scheduled to undergo surgical treatment for skin cancer on the lower extremities and have no other surgeries scheduled in the coming weeks after the procedure
- Will have a surgical wound that will be left open to heal by secondary intention
Key exclusion criteria (4 listed)
- Age under 18 years old
- Have a known allergy to chlorhexidine or mupirocin
- Have a history of Staphylococcus aureus infection
- Have a history of heart valve or joint replacement surgery requiring pre-operative antibiotics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorhexidine gluconate (4%)Also: HibiclensChlorhexidine 4% solution will be applied from the neck down (avoiding the face, penis, and vagina), allowed to sit on the skin for one minute, then rinsed off in the shower every day for 5 days prior to surgery. | Drug | Treatment Group |
| Mupirocin 2% OintmentMupirocin 2% ointment will be applied to the inside of the nostrils twice daily, in the morning and evening, for 5 days prior to surgery. A small amount of the ointment will be placed on the tip of a cotton swab to facilitate application to each nostril. | Drug | Treatment Group |
Primary outcome
Number of Participants with Surgical Site Wound Infection
Time frame: From date of surgery to 1-month post-operation
Signs of infection, including erythema, edema, drainage, and delayed healing, will be visually determined by study physicians with photographs of the surgical site collected from study participants. All patients will be followed up with a phone call at 1 month to monitor for any adverse events and additional signs of infection including pain, tenderness, warmth, and foul odor at the surgical site.
1 secondary outcome
Type of Pathogens Present in Surgical Site
Time frame: From date of surgery to 1-month post-operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Background: PubMed 30204741Smith H, Borchard K, Cherian P, Tai Y, Vinciullo C. Randomized Controlled Trial of Preoperative Topical Decolonization to Reduce Surgical Site Infection for Staphylococcus aureus Nasal Swab-Negative Mohs Micrographic Surgery Patients. Dermatol Surg. 2019 Feb;45(2):229-233. doi: 10.1097/DSS.0000000000001662.
- Background: PubMed 24090258Cherian P, Gunson T, Borchard K, Tai Y, Smith H, Vinciullo C. Oral antibiotics versus topical decolonization to prevent surgical site infection after Mohs micrographic surgery--a randomized, controlled trial. Dermatol Surg. 2013 Oct;39(10):1486-93. doi: 10.1111/dsu.12318.
- Background: PubMed 31415257Molina GE, Yu SH, Neel VA. Observations Regarding Infection Risk in Lower-Extremity Wound Healing by Second Intention. Dermatol Surg. 2020 Oct;46(10):1342-1344. doi: 10.1097/DSS.0000000000002094. No abstract available.
- Background: PubMed 16792648Dixon AJ, Dixon MP, Askew DA, Wilkinson D. Prospective study of wound infections in dermatologic surgery in the absence of prophylactic antibiotics. Dermatol Surg. 2006 Jun;32(6):819-26; discussion 826-7. doi: 10.1111/j.1524-4725.2006.32167.x.
- Background: PubMed 29136259Liu X, Sprengers M, Nelemans PJ, Mosterd K, Kelleners-Smeets NWJ. Risk Factors for Surgical Site Infections in Dermatological Surgery. Acta Derm Venereol. 2018 Feb 7;98(2):246-250. doi: 10.2340/00015555-2844.
- Background: PubMed 32483093Schimmel J, Belcher M, Vieira C, Lawrence N, Decker A. Incidence of Surgical Site Infections in Second Intention Healing After Dermatologic Surgery. Dermatol Surg. 2020 Dec;46(12):1492-1497. doi: 10.1097/DSS.0000000000002409.
- Individual participant dataSharing planned: Undecided. We have not decided whether or not individual participant data (IPD) will be shared, however, if we do, only IPD used in the results publication will be included.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chlorhexidine gluconate (4%) and Mupirocin 2% Ointment in people with Surgical Wound Infection, run by Cooper Norcross Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naomi Lawrence, MD ((856) 596-3040, lawrence-naomi@cooperhealth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Surgical Site Wound Infection (time frame: From date of surgery to 1-month post-operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07142408, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.